Study Start-up Specialist, Sponsor-dedicated

1 week ago

Maidenhead, United Kingdom Fortrea Full time

Labcorp Drug Development has supported the pharmaceutical industry in developing more medicines worldwide than any other company, including the top 50 best-selling drugs on the market today. Join us and see why more than 90% of the top 20 global pharmaceutical companies are repeat customers

If you are looking to take on responsibility and leverage your know-how in the start-up phase of clinical trials - ensuring a successful start of important clinical studies in the UK -, this is the perfect opportunity. You will be working alongside our dedicated and supportive team of SSU experts and exclusively for one of our renowned international sponsors - in a role that allows you to have a real impact on people’s health and lives.

What we have to offer: a strong international support network, flexible working solutions that facilitate a genuine work-life balance, a highly competitive compensation package and the opportunity to significantly raise your profile in the industry.

This role can be a mix of home-based and Office based, and as such you must be based in the South East of England.

Your tasks:

- Independently manages multiple country, study and site level deliverables during start-up and maintenance both within the client and external business partners and vendors, when required.
- Plans and develops strategy for start-up activities to ensure successful recruitment and delivery to trial milestones
- Prepare Investigator Sites to conduct clinical trials through the review and approval of essential clinical trial and regulatory documents
- Support local regulatory in preparing and performing submissions for Health Authorities including follow up until approval. This includes substantial amendments and any other documentation requiring HA submission.
- Prepare and perform submissions for Ethics Committees including follow up until approval (protocol, amendments/IB and any other documents requiring EC submission).
- Collaborates with other internal roles in country feasibility and site selection.
- Collaborates directly with the client's internal study teams, external site staff, country ethics committees/IRB to ensure tasks and priorities are aligned to the defined study timelines
- Prepare country Informed Consent Form (ICF) and manage country ICF template
- Review and approval of Site ICFs
- Review and approval of Clinical Trial Package (CTP) documentation
- Update national registries as applicable
- Ensures that the electronic Trial Master File (eTMF) contains the relevant Clinical Trial Package (CTP) regulatory documents for site activation and ongoing study management
- When applicable, conduct drug/IMP label review & translation
- Serves as expert on country regulatory requirements and keeps up to date with evolving regulation in collaboration with Regulatory and legal
- May support the collection and distribution of documents from / to sites including obtaining insurance certificates
- May support Health Authority inspection and pre-inspection activities
- May support audit preparation & Corrective Action / Preventative Action preparation for local related issues

**Education**:
- Degree in a relevant field such as pharmacology, life sciences, clinical trial management, (veterinarian) medicine, health care (management), nursing, chemistry, biology, oecotrophology etc.,- In lieu of the above, an equivalent completed vocational education or equivalent professional experience

**Experience**:
- Solid expertise in clinical trials within a CRO or a pharmaceutical company with a specialization in clinical study start up / regulatory processes- Demonstrated understanding of research protocol requirements as well as the ability to communicate them / educate others about them- Proven track record collaborating successfully with operational project teams as well as external investigative sites and local regulatory authorities (including IRBs and IECs)- In-depth experience with submissions to the UK regulatory authorities - observing all local regulations and guidelines as well as international standards such as ICH and GCP- Familiarity with investigator start-up documents and contract / budget negotiation processes with study sites- Autonomous work style with excellent time and project management skills- Business fluency in English - both spoken and written - is a must

REMOTE

Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, gene

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